BioTox Dental Foci Repair: Homeopathic Product Information

BIOTOX DENTAL FOCI REPAIR- arnica montana whole, hypericum perforatum whole, plantago major whole, aconitum napellus whole, mercurius solubilis, hekla lava, silver nitrate, atropa belladonna, calcium sulfide and silicon dioxide spray
The Wellness Center For Research and Education

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

ACTIVE INGREDIENTS:

Arnica Montana 3C, 6C, 30C, 60C, 200C, Hypericum Perforatum 3C, 6C, 30C, 60C, 200C, Plantago Major 3C, 6C, 30C, 60C, 200C, Aconitum Napellus 4C, 6C, 30C, 60C,200C, Mercurius Solubilis 4C, 6C, 30C, 60C,200C, Hekla Lava 6C, 30C, Argentum Nitricum 6C, 30C, 60C, 200C, Belladonna 6C, 30C, 60C, 200C, Hepar Sulphuris Calcareum 6C, 30C, 60C, 200C, Silicea 6C, 30C, 60C, 200C.

INDICATIONS:

For Temporary relief from right-sided tooth discomfort, dental abscess, tooth decay, loose teeth, nerve pain and general oral discomfort, Supports the body’s natural slowing of excess bleeding. Promotes healthy gums.

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Spray orally, 2 to 4 sprays twice daily on affected teeth or gums, at least 30 minutes before or after eating. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For Temporary relief from right-sided tooth discomfort, dental abscess, tooth decay, loose teeth, nerve pain and general oral discomfort, Supports the body’s natural slowing of excess bleeding. Promotes healthy gums.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Organic Ethanol.

QUESTONS:

MFD FOR: The Wellness Center for

Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

PACKAGE LABEL DISPLAY:

Dr. Theresa Dale’s

NDC 50181-0082-1

Homeopathic

BioTox

Dental Foci

Repair

1 fl oz (30 ml)

BIOTOX DENTAL FOCI REPAIR arnica montana, hypericum perforatum, plantago major, aconitum napellus, mercurius solubilis, hekla lava, argentum nitricum, belladonna, hepar sulphuris calcareum, silicea spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50181-0082 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA WHOLE (ARNICA MONTANA) ARNICA MONTANA WHOLE 3 [hp_C] in 1 mL HYPERICUM PERFORATUM WHOLE (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM WHOLE 3 [hp_C] in 1 mL PLANTAGO MAJOR WHOLE (PLANTAGO MAJOR) PLANTAGO MAJOR WHOLE 3 [hp_C] in 1 mL ACONITUM NAPELLUS WHOLE (ACONITUM NAPELLUS) ACONITUM NAPELLUS WHOLE 4 [hp_C] in 1 mL MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 4 [hp_C] in 1 mL HEKLA LAVA (HEKLA LAVA) HEKLA LAVA 6 [hp_C] in 1 mL SILVER NITRATE (SILVER CATION) SILVER NITRATE 6 [hp_C] in 1 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 6 [hp_C] in 1 mL CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 6 [hp_C] in 1 mL SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 6 [hp_C] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50181-0082-1 30 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/14/2022

Labeler — The Wellness Center For Research and Education (832363993)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (50181-0082), api manufacture (50181-0082), label (50181-0082), manufacture (50181-0082)

Revised: 02/2022 The Wellness Center For Research and Education